A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
The FDA has sent Navidea a complete response letter (CRL) on its Lymphoseek injection, citing concerns over quality control at third-party contract manufacturing facilities. The CRL followed an FDA inspection of those facilities and was not related to any safety or efficacy issues with Lymphoseek (technetium Tc 99m tilmanocept), the company added. It did not provide details about the good manufacturing practice issues raised in the letter. Drug Industry Daily